Cleared Traditional

K080451 - UNIBLATE ELECTROSURGICAL DEVICE

K080451 is the FDA 510(k) clearance for UNIBLATE ELECTROSURGICAL DEVICE by AngioDynamics, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K080451 · AngioDynamics, Inc. · General & Plastic Surgery device
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Jul 2008
Decision
135d
Days
Class 2
Risk

K080451 is an FDA 510(k) clearance for the UNIBLATE ELECTROSURGICAL DEVICE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on July 3, 2008 after a review of 135 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all AngioDynamics, Inc. devices

Submission Details

510(k) Number K080451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2008
Decision Date July 03, 2008
Days to Decision 135 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 115d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1069
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K080451.
GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003
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GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE
K081954 · Gyrus Acmi, Inc. · Jul 2008
ONCOBIONIC BIPOLAR ELECTRODE
K080287 · AngioDynamics, Inc. · Jul 2008
CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL
K081634 · Conmed Corporation · Jun 2008
BEAMER ARGON SNARE PROBE
K081580 · Conmed Corporation · Jun 2008
PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
K080093 · Gyrus Acmi, Inc. · May 2008